- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07588165
Pain Assessment During Rapid Sequence Induction (NARSI)
Nociception Assessment During Rapid Sequence Induction: A Prospective Observational Study of Practices and Complications - The NARSI Study
Rapid sequence induction (RSI) is a standard anesthesia technique used in patients at risk of aspiration. Although tracheal intubation following RSI is a frequent and painful procedure, no study has yet evaluated nociception using the Analgesia Nociception Index (ANI) during this procedure.
This monocentric prospective observational study aims to describe the impact of RSI on pain measured by ANI, and to explore early complications (desaturation, hypotension, regurgitation) and factors associated with pain and complications. 150 patients undergoing RSI in the visceral surgery operating room at CHPG Monaco will be analyzed.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Background: RSI is a standard technique in anesthesia, primarily used to minimize the risk of aspiration. European guidelines leave the choice of hypnotic and neuromuscular blocking agent to the practitioner; the role of analgesics is not addressed. RSI induces sympathetic reactions linked to intense painful stimulation. Several monitors enable nociception assessment during general anesthesia, including in paralyzed patients (ANI, NOL, SPI). To date, no study has explored pain using the Analgesia Nociception Index during RSI.
Hypothesis: Rapid sequence induction induces sympathetic reactions associated with intense painful stimulation, which can be quantified using ANI.
Primary objective: To describe the impact on pain monitored by ANI of rapid sequence induction in anesthesia.
Secondary objectives: (1) Describe early complications (desaturation, hypotension, regurgitation); (2) Explore factors associated with pain; (3) Explore factors associated with complications.
Methods: Prospective monocentric observational cohort study, in routine care, with no additional examinations beyond standard management. Patients are monitored according to Société Française d'Anesthésie et de Réanimation (SFAR) guidelines, with additional non-invasive cutaneous electrodes placed on the right pectoral area for ANI monitoring. Induction begins after preoxygenation of at least 3 minutes. Induction drugs are at the discretion of the anesthesiologist. A timer is started at injection of the first induction drug (T0). Hemodynamic and ANI parameters are recorded during the first 5 minutes.
Data collected: date of intervention, age, sex, ASA score, Mallampati score, Cormack classification, preoperative analgesics (paracetamol within 4h, nefopam, tramadol, morphine, ketoprofen), induction drugs (hypnotic: propofol/etomidate/ketamine; opioid: remifentanil/alfentanil/sufentanil; neuromuscular blocker: succinylcholine/rocuronium), heart rate and systolic/diastolic blood pressure (T preO2, T1min, T3min, T5min), ANI and SpO2 (T preO2, minimum value <5min), intubation device (McGrath / Airtraq / direct laryngoscopy), time between neuromuscular blocker injection and cuff inflation, presence of postoperative sore throat at 24h.
Statistical analysis: descriptive analysis of patient characteristics; mixed models for evaluation of variables over the 5 minutes post-RSI; multivariate models to identify associated risk factors. Two-sided p-values <0.05 will be considered statistically significant. Analyses performed with R software.
Follow-up duration: 24 hours per patient. Total inclusion period: 24 months.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Celine DUGOURD
- Telefonní číslo: +377 97 98 84 29
- E-mail: recherche.clinique@chpg.mc
Studijní záloha kontaktů
- Jméno: Remy WIDEHEM
- Telefonní číslo: +377 97 98 99 00
- E-mail: remy.widehem@chpg.mc
Studijní místa
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-
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Monaco, Monako, 98000
- Nábor
- Centre Hospitalier Princesse Grace
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Kontakt:
- Rémy WIDEHEM, MD
- Telefonní číslo: 0037797989900
- E-mail: remy.widehem@chpg.mc
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Age >= 18 years
- Patient requiring tracheal intubation after rapid sequence induction in the visceral surgery operating room
- Pain monitoring by Analgesia Nociception Index (ANI) as part of general anesthesia
Exclusion Criteria:
- Patient with atrial fibrillation at the time of intubation following rapid sequence induction
- Patient on long-term beta-blocker therapy
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Variation of the Analgesia Nociception Index (ANI) during the 5 minutes following rapid sequence intubation
Časové okno: 5 minutes post-induction
|
5 minutes post-induction
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Variation of hemodynamic parameters (heart rate, systolic and diastolic blood pressure) during the 5 minutes post-RSI
Časové okno: 5 minutes post-induction
|
5 minutes post-induction
|
|
Occurrence of regurgitation during RSI
Časové okno: 5 minutes post-induction
|
5 minutes post-induction
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|
First-attempt intubation success rate
Časové okno: At time of intubation
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At time of intubation
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Variation of SpO2 during the 5 minutes post-RSI
Časové okno: 5 minutes post-induction
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5 minutes post-induction
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Identification of factors associated with reduced pain (lower ANI variation)
Časové okno: 5 minutes post-induction
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5 minutes post-induction
|
|
Presence of sore throat 24 hours after intubation
Časové okno: 24 hours post-intubation
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24 hours post-intubation
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Remy WIDEHEM, MD, Centre Hospitalier Princesse Grace
Publikace a užitečné odkazy
Obecné publikace
- Sajayan A, Wicker J, Ungureanu N, Mendonca C, Kimani PK. Current practice of rapid sequence induction of anaesthesia in the UK - a national survey. Br J Anaesth. 2016 Sep;117 Suppl 1:i69-i74. doi: 10.1093/bja/aew017. Epub 2016 Feb 24.
- Funcke S, Sauerlaender S, Pinnschmidt HO, Saugel B, Bremer K, Reuter DA, Nitzschke R. Validation of Innovative Techniques for Monitoring Nociception during General Anesthesia: A Clinical Study Using Tetanic and Intracutaneous Electrical Stimulation. Anesthesiology. 2017 Aug;127(2):272-283. doi: 10.1097/ALN.0000000000001670.
- Acquisto NM, Mosier JM, Bittner EA, Patanwala AE, Hirsch KG, Hargwood P, Oropello JM, Bodkin RP, Groth CM, Kaucher KA, Slampak-Cindric AA, Manno EM, Mayer SA, Peterson LN, Fulmer J, Galton C, Bleck TP, Chase K, Heffner AC, Gunnerson KJ, Boling B, Murray MJ. Society of Critical Care Medicine Clinical Practice Guidelines for Rapid Sequence Intubation in the Critically Ill Adult Patient. Crit Care Med. 2023 Oct 1;51(10):1411-1430. doi: 10.1097/CCM.0000000000006000. Epub 2023 Sep 14.
- Alanoglu Z, Tolu S, Yalcin S, Batislam Y, Ozatamer O, Tuzuner F. Different remifentanil doses in rapid sequence anesthesia induction: BIS monitoring and intubation conditions. Adv Clin Exp Med. 2013 Jan-Feb;22(1):47-55.
- O'Hare R, McAtamney D, Mirakhur RK, Hughes D, Carabine U. Bolus dose remifentanil for control of haemodynamic response to tracheal intubation during rapid sequence induction of anaesthesia. Br J Anaesth. 1999 Feb;82(2):283-5. doi: 10.1093/bja/82.2.283.
- Chaumeron A, Castanie J, Fortier LP, Basset P, Bastide S, Alonso S, Lefrant JY, Cuvillon P. Efficacy and safety of remifentanil in a rapid sequence induction in elderly patients: A three-arm parallel, double blind, randomised controlled trial. Anaesth Crit Care Pain Med. 2020 Apr;39(2):215-220. doi: 10.1016/j.accpm.2019.09.010. Epub 2019 Oct 12.
- Voeltzel J, Garnier O, Prades A, Carr J, De Jong A, Molinari N, Jaber S, Chanques G. Assessing pain in paralyzed critically ill patients receiving neuromuscular blocking agents: A monocenter prospective cohort. Anaesth Crit Care Pain Med. 2024 Aug;43(4):101384. doi: 10.1016/j.accpm.2024.101384. Epub 2024 May 6.
- Gruenewald M, Herz J, Schoenherr T, Thee C, Steinfath M, Bein B. Measurement of the nociceptive balance by Analgesia Nociception Index and Surgical Pleth Index during sevoflurane-remifentanil anesthesia. Minerva Anestesiol. 2015 May;81(5):480-9. Epub 2014 Jul 17.
- Grillot N, Gonzalez V, Deransy R, Rouhani A, Cintrat G, Rooze P, Naux E, Volteau C, Bouras M, Cinotti R, Roquilly A. Post-induction hypotension during rapid sequence intubation in the operating room: A post hoc analysis of the randomized controlled REMICRUSH trial. Anaesth Crit Care Pain Med. 2025 May;44(3):101502. doi: 10.1016/j.accpm.2025.101502. Epub 2025 Mar 12.
- Grillot N, Lebuffe G, Huet O, Lasocki S, Pichon X, Oudot M, Bruneau N, David JS, Bouzat P, Jobert A, Tching-Sin M, Feuillet F, Cinotti R, Asehnoune K, Roquilly A; Atlanrea Study GroupSociete Francaise d'Anesthesie Reanimation (SFAR) Research Network. Effect of Remifentanil vs Neuromuscular Blockers During Rapid Sequence Intubation on Successful Intubation Without Major Complications Among Patients at Risk of Aspiration: A Randomized Clinical Trial. JAMA. 2023 Jan 3;329(1):28-38. doi: 10.1001/jama.2022.23550.
- Greer A, Hewitt M, Khazaneh PT, Ergan B, Burry L, Semler MW, Rochwerg B, Sharif S. Ketamine Versus Etomidate for Rapid Sequence Intubation: A Systematic Review and Meta-Analysis of Randomized Trials. Crit Care Med. 2025 Feb 1;53(2):e374-e383. doi: 10.1097/CCM.0000000000006515. Epub 2024 Nov 21.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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